Neural Stem Cells Therapy for Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Neural Stem Cells Therapy for Cerebral Palsy: a Prospective, Randomized, Parallel-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03005249
• Other study ID #: LCKY2016-60
• Status: Recruiting
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2019

Study information

• Verified date: February 2018
• Source: The First Affiliated Hospital of Dalian Medical University
• Contact: Jing Liu, Ph.D
• Phone: 86041184394568
• Email: liujing.dlrmc[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of neural stem cells (NSCs) therapy for cerebral palsy.

Description:

Cerebral palsy is the most severe lifelong disability disease in childhood. In China, an epidemiological investigation of cerebral palsy in 2004 has reported that 2.74‰ (about 6.50-9.75 million) of children suffered from cerebral palsy. The costs of medical expenses, living allowance and nursing care can go up to RMB 20000-50000 yuan per year for each child with cerebral palsy and thus China will expend RMB 120-300 billion yuan per year for children with cerebral palsy. With full liberalization of two-child policy, there is an increasing number of second babies born to women who are 35 years or older. Thus, the incidence of cerebral palsy tends to increase. There is currently no cure for cerebral palsy, resulting in a heavy burden for families and on society. Recent clinical trials performed in countries outside China have demonstrated that stem cell therapy is likely the most effective method to treat cerebral palsy. Fifteen trials regarding stem cell therapy for cerebral palsy have been registered with ClinicalTrials.gov. In China, there have been no standardized registered trials regarding stem cell therapy for cerebral palsy, which greatly restricts its clinical application. In October 2016, the National Health and Family Planning Commission and the Food and Drug Administration of China jointly announced the premier stem cell clinical research institutions, making performing standardized trials regarding stem cell therapy for cerebral palsy in China possible.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

Inclusion Criteria:

• Neonates with ischemic/hypoxic cerebral palsy (mainly including neonate with asphyxia and premature infants);

• Clinical manifestation of spastic tetraplegia;

• With moderate to severe cerebral palsy, The Gross Motor Function; Classification System (GMFCS) levels IV-V;

• Age 1-5 years, of either sex;

• Provision of signed informed consent by one of his/her parents or legal guardians prior to commencement of this study;

Exclusion Criteria:

• Systemic diseases that possibly influence treatment or patient's compliance;

• Potentially life-threatening diseases involving various organ systems;

• Brain deformity;

• Abnormal behaviors or mood disorder;

• Allergies from blood products;

• Suffering from infectious disease;

• Subjected to craniocerebral operations prior to screening.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Procedure:
• neural stem cells therapy group
The patients will be assigned to neural stem cells therapy group for cerebral palsy.

Other:
• the control group
The patients will be assigned to the control group for cerebral palsy.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GMFM-88 score	To evaluate change in gross motor function in children with cerebral palsy.	changes of month 1, month 3, month 6, month 9 and month 12 after therapy
Secondary	Fine Motor Function Measure (FMFM) score	To evaluate change in fine motor function in children with cerebral palsy.	changes of month 1, month 3, month 6, month 9 and month 12 after therapy
Secondary	Modified Ashworth Scale score	To measure resistance during passive soft-tissue stretching and is used as a simple measure of spasticity.	changes of month 1, month 3, month 6, month 9 and month 12 after therapy